Label: SINUS PRESSURE PAIN MAXIMUM STRENGTH, NON-DROWSY- acetaminophen, phenylephrine hcl tablet
- NDC Code(s): 46122-443-62
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
GOOD
NEIGHBOR
PHARMACY®Compare to SUDAFED PE® SINUS
PRESSURE + PAIN active ingredients*NDC 46122-443-62
MAXIMUM STRENGTH
Sinus Pressure/Pain
acetaminophen, phenylephrine HCl
pain reliever/fever reducer & nasal decongestantNon-Drowsy
Relief of:
• Sinus Headache • Sinus Pressure • Nasal Congestion24 Caplets
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERINGDistributed By
Amerisource Bergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.comGOOD NEIGHBOR PHARMACY BRAND PRODUCTS
SATISFACTION GUARANTEED*This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark SUDAFED
PE® SINUS PRESSURE + PAIN.50844 REV0820B50208
GNP 44-502
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INGREDIENTS AND APPEARANCE
SINUS PRESSURE PAIN MAXIMUM STRENGTH, NON-DROWSY
acetaminophen, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-443 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color orange Score no score Shape OVAL Size 18mm Flavor Imprint Code 44;502 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-443-62 2 in 1 CARTON 06/23/2005 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/23/2005 Labeler - Amerisource Bergen (007914906) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(46122-443) , pack(46122-443) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(46122-443)